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Tirapazamine

Phase 3

Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Sanofi|Last Updated: May 26, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment317

FDA Designations

No designations recorded

Clinical trial landscape

Tirapazamine · 3 trials · 3 indications

Phase 3 3
NCT00174837TRACE: Tirapazamine-Radiation And Cisplatin EvaluationHead and Neck Squamous Cell Carcinoma
COMPLETED317 Analytics
NCT00094081Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck CancerHead and Neck Neoplasms
COMPLETED861 Analytics
NCT00017459Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung Cancer
COMPLETED- Analytics
PHASE3COMPLETED
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Head and Neck Squamous Cell CarcinomaUnlock trial analytics
PHASE3COMPLETED
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
Head and Neck NeoplasmsUnlock trial analytics
PHASE3COMPLETED
Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival
Study period
Overall survival.

Secondary Endpoints

Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Study period
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Study period
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tirapazamine + CisplatinEXPERIMENTAL -
CisplatinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
TirapazamineDRUGin combination with cisplatin and concomitant radiation
CisplatinDRUGwith concomitant radiation
tirapazamine (SR259075)DRUG -
Radiation TherapyPROCEDURE -
vinorelbine tartrateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. * Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease). * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Absolute ...

Countries:United StatesArgentinaAustraliaCanadaChileFranceGermanyHong KongHungaryItalyNew ZealandPolandSingaporeSouth AfricaSpainSwitzerlandTaiwan
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Frequently asked questions about Tirapazamine

What is Tirapazamine used for?

Tirapazamine is an investigational small molecule being studied for the treatment of head and neck squamous cell carcinoma, head and neck neoplasms, and lung cancer. It is in Phase 3 clinical development for these oncology indications.

Who makes Tirapazamine?

Tirapazamine is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. The drug is an investigational small molecule in Phase 3 clinical development for oncology indications.

What phase is Tirapazamine in?

Tirapazamine is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for head and neck squamous cell carcinoma, head and neck neoplasms, and lung cancer.

What clinical trials is Tirapazamine in?

Tirapazamine has been studied in three Phase 3 clinical trials: NCT00017459 for lung cancer, NCT00094081 for head and neck neoplasms, and NCT00174837 for head and neck squamous cell carcinoma. All three trials have been completed.

Is Tirapazamine the same as any other drug?

Tirapazamine is also known by the name SR 4233. It is an investigational small molecule being developed by Sanofi for the treatment of head and neck squamous cell carcinoma, head and neck neoplasms, and lung cancer.